Life Spine Receives FDA Clearance for PROLIFT Expandable Interbody System
Life Spine received FDA 510(k) clearance to market the PROLIFT® Expandable Interbody System for use in minimally invasive PLIF, TLIF and oblique approaches. Mar 08, 2016
Instratek Launches HammerFIT Extremity Reamers
Instratek commenced U.S. launch of the HammerFIT™ Extremity Reamer for hammertoe surgery. Mar 08, 2016
Medtronic Launches AVILA Interbody Fusion Devices in the EU
Medtronic commenced EU launch of AVILA™ devices, intended for use in open and minimally invasive anterior and oblique lumbar interbody fusion from L2-S1 levels. Mar 08, 2016
FDA Panel to Convene on PMA for Cartiva’s Synthetic Cartilage Implant
On 4/20/16, FDA’s Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Cartiva’s Synthetic Cartilage Implant, an organic polymer-based biomaterial designed to mimic biologic cartilage. Mar 08, 2016
OrthoSensor in Strategic Partnership with Electronics Company IM-Tech
OrthoSensor entered into a partnership with IM-Tech to support R&D collaboration, manufacturing and investments in electronics technology in the global commercialization of the VERASENSE™ sensor. Mar 08, 2016
NuVasive to Acquire Mega Surgical, Brazilian Distributor
NuVasive entered into a definitive agreement to acquire Mega Surgical, its exclusive distributor in Brazil. The transaction is expected to close within 1Q16. Mar 07, 2016
FDA Accepts Vericel’s BLA for MACI for in Knee Cartilage Defects
FDA has accepted for filing Vericel’s BLA for MACI™, matrix-applied characterized autologous cultured chondrocytes intended to treat adult symptomatic knee cartilage defects. Mar 07, 2016
FDA Clearance of Stryker Tritanium PL Posterior Lumbar Cage
Stryker Spine announced FDA 510(k) clearance of Tritanium® PL, a highly-porous posterior lumbar cage manufactured via 3D additive manufacturing. Launch will occur in 2Q16. Mar 04, 2016
Zimmer Biomet Secures Global Distribution Agreement with CelgenTek
Zimmer Biomet entered into an exclusive global distribution agreement for CelgenTek Innovations’ N-Force Fixation System® and iN3 Cement. Mar 04, 2016
FDA Clears Compatibility of ZBH Nexel Total Elbow with the Comprehensive Segmental Revision System
Zimmer Biomet (ZBH) received FDA 510(k) clearance for compatibility of the Nexel™ Total Elbow with the Comprehensive® Segmental Revision System. This marks the 1st submission by ZBH to establish compatibility of two separate ZBH implant systems. Mar 03, 2016
